Home NDC 50580-132 TYLENOL COLD PLUS FLU MULTI-SYMPTOM GELS DAY PLUS NIGHT
Product NDC 50580-132
11-digit product format 505800132
Labeler code 50580
Product ID 50580-132_58d76586-b95a-dcb2-e063-6394a90a8b26
Type HUMAN OTC DRUG
Nonproprietary name acetaminophen,dextromethorphan hydrobromide, doxylamine succinate
Dosage form KIT
Labeler Kenvue Brands LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-09-25
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base TYLENOL COLD PLUS FLU MULTI-SYMPTOM GELS DAY PLUS NIGHT
Listing expiration 2027-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1094549 Internal RxNorm lookup 1867684 Internal RxNorm lookup 2676954 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50580-132-24 TYLENOL COLD PLUS FLU MULTI-SYMPTOM GELS DAY PLUS NIGHT 1 in 1 PACKAGE KIT 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50580-132 TYLENOL COLD PLUS FLU MULTI-SYMPTOM GELS DAY PLUS NIGHT (ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) KIT [KENVUE BRANDS LLC] 3 Current NDC, 1 package rows 20241215_1c5578e6-7e67-c467-e063-6294a90a6e0b.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 73 of 178 · 3,550 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 50580-132-24 50580013224 1 KIT in 1 PACKAGE (50580-132-24) * 2 BLISTER PACK in 1 KIT / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 1 BLISTER PACK in 1 KIT / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 1 kit 2024-09-25 No No Current